Vizarsin 100mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sildenafil citrate

Available from:

Consilient Health Ltd

ATC code:

G04BE03

INN (International Name):

Sildenafil citrate

Dosage:

100mg

Pharmaceutical form:

Tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 07040500; GTIN: 5391512452230

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VIZARSIN 100 MG FILM-COATED TABLETS
Sildenafil
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vizarsin is and what it is used for
2.
What you need to know before you take Vizarsin
3.
How to take Vizarsin
4.
Possible side effects
5.
How to store Vizarsin
6.
Contents of the pack and other information
1.
WHAT VIZARSIN IS AND WHAT IT IS USED FOR
Vizarsin contains the active substance sildenafil which belongs to a
group of medicines called
phosphodiesterase type 5 (PDE5) inhibitors. It works by helping to
relax the blood vessels in your
penis, allowing blood to flow into your penis when you get sexually
excited. Vizarsin will only help
you to get an erection if you are sexually stimulated.
Vizarsin is a treatment for adult men with erectile dysfunction,
sometimes known as impotence. This
is when a man cannot get, or keep a hard, erect penis suitable for
sexual activity.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIZARSIN
DO NOT TAKE VIZARSIN:
-
If you are allergic to sildenafil or any of the other ingredients of
this medicine (listed in section
6).
-
If you are taking medicines called nitrates, as the combination may
lead to a dangerous fall in
your blood pressure. Tell your doctor if you are taking any of these
medicines which are often
given for relief of angina pectoris (or “chest pain”). If you are
not certain, ask your doctor or
pharmacist.
-
If you are using any of the medicines known as nitric oxide donors
such as amyl nitrite
(“poppers”), as th

Summary of Product characteristics

OBJECT 1
VIZARSIN 100 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 05-Dec-2013 | Consilient
Health Ltd
1. Name of the medicinal product
Vizarsin 100 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 100 mg sildenafil (as citrate).
Excipient with known effect:
Each film-coated tablet contains 8 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet.
White, oblong tablets, marked “100“ on one side.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of men with erectile dysfunction, which is the inability to
achieve or maintain a penile erection
sufficient for satisfactory sexual performance.
In order for Vizarsin to be effective, sexual stimulation is required.
4.2 Posology and method of administration
For oral use.
_Use in adults:_
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity. Based
on efficacy and toleration, the dose may be increased to 100 mg or
decreased to 25 mg. The maximum
recommended dose is 100 mg. The maximum recommended dosing frequency
is once per day. If Vizarsin
is taken with food, the onset of activity may be delayed compared to
the fasted state (see section 5.2).
_Use in the elderly:_
Dosage adjustments are not required in elderly patients.
_Use in patients with impaired renal function:_
The dosing recommendations described in 'Use in adults' apply to
patients with mild to moderate renal
impairment (creatinine clearance = 30-80 ml/min).
Since sildenafil clearance is reduced in patients with severe renal
impairment (creatinine clearance <30
ml/min) a 25 mg dose should be considered. Based on efficacy and
toleration, the dose may be increased
to 50 mg and 100 mg.
_Use in patients with impaired hepatic function:_
Since sildenafil clearance is reduced in patients with hepatic
impairment (e.g. cirrhosis) a 25 mg dose
should be considered. Based on efficacy and toleration, the dose may
be increased to 50 mg and 100